Frame features for prosthetic mitral valves

ABSTRACT

Prosthetic heart valves are described herein that can provide clearance to the left ventricle outflow tract (LVOT), reduce the possibility of undesirable outflow gradients, and/or limit or prevent LVOT obstructions when implanted in the heart. In some embodiments, a prosthetic heart valve can include an outer frame having a cuff portion that is disposed at an angle (e.g., 80 degrees) relative to the vertical axis of a body portion of the outer frame, so that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart. In some embodiments, a prosthetic heart valve can alternatively, or additionally, include subvalvular components having a short profile, such that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International PCT Application No.PCT/US2016/064610, entitled “Frame Features for Prosthetic MitralValves”, filed Dec. 2, 2016, which claims priority to and the benefit ofU.S. Provisional Patent Application No. 62/262,511, filed Dec. 3, 2015,entitled “Frame Features for Prosthetic Mitral Valves,” each of thedisclosures of which is incorporated herein by reference in itsentirety.

BACKGROUND

Prosthetic heart valves, including those for insertion intoatrioventricular valves (tricuspid and mitral valves) are susceptible tovarious problems, including problems with ventricular outflow tractobstruction. Some known prosthetic mitral valves, for example, applyundesirable forces to the anterior segment of the native valve therebycontributing to undesirable interruption of blood flow into the aorta,which anatomically sits immediately behind the anterior segment of themitral annulus. As another example, some known prosthetic mitral valvesinclude subvalvular components that obstruct the left ventricularoutflow tract (LVOT) and/or direct blood flow from the atrium to theventricle in a manner that creates undesirable flow gradients and LVOTinterruption. Accordingly, there is still a need for a prosthetic heartvalve that can address some or all of these problems.

SUMMARY

Prosthetic heart valves are described herein that can provide clearanceto the LVOT, reduce the possibility of undesirable outflow gradients,and/or limit or prevent LVOT obstructions when implanted in the heart.In some embodiments, a prosthetic heart valve can include an outer frameassembly including an outer frame having a cuff portion configured to bedisposed at least partially within an atrium of a heart and a bodyportion configured to be disposed in a ventricle of the heart. The bodyportion has a posterior side and an opposite anterior side and theanterior side can have a maximum height larger than a maximum height ofthe posterior side such that when the prosthetic heart valve is disposedwithin a native annulus of the heart, an anterior end of the outer frameis disposed at an acute angle relative to a centerline of the outerframe. An inner valve assembly is disposed within and coupled to theouter frame assembly and includes an inner frame having an atrium endand a ventricle end and having a centerline substantially parallel tothe centerline of the outer frame. The inner valve assembly includes avalve leaflet assembly supported on the inner frame.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are schematic perspective and side cross sectional viewsof a prosthetic heart valve according to an embodiment.

FIGS. 2A-C are schematic views of an inner valve assembly of theprosthetic heart valve of FIGS. 1A and 1B.

FIG. 3 is a top view of a prosthetic heart valve according to anotherembodiment.

FIG. 4 is a top view of a prosthetic heart valve according to anotherembodiment.

FIG. 5 is a perspective side view of a portion of a prosthetic heartvalve according to another embodiment.

FIG. 6 is an exploded view of a prosthetic heart valve system accordingto another embodiment.

FIGS. 7-9 are front, bottom, and top views of a prosthetic heart valveaccording to another embodiment.

FIG. 10 is an opened and flattened view of the inner frame of the valveof FIGS. 7-9, in an unexpanded configuration.

FIGS. 11 and 12 are side and bottom views, respectively, of the innerframe of FIG. 10 in an expanded configuration.

FIG. 13 is an opened and flattened view of the outer frame of the valveof FIGS. 7-9, in an unexpanded configuration.

FIGS. 14 and 15 are side and top views, respectively, of the outer frameof FIG. 13 in an expanded configuration.

FIGS. 16-18 are side, front, and top views of an assembly of the innerframe of FIGS. 10-12 and the outer frame of FIGS. 13-15.

FIG. 19 is a plan view of a fabric pattern for the inner and outercoverings of the outer frame assembly of the valve of FIGS. 7-9.

FIG. 20 is a plan view of a fabric pattern for the leaflets and outercovering of the inner valve assembly of the valve of FIGS. 7-9.

FIGS. 21 and 22 are schematic perspective and side cross sectional viewsof a prosthetic heart valve according to another embodiment.

FIGS. 23-25 are top and perspective views of a prosthetic heart valveaccording to another embodiment.

FIG. 26 is an exploded view of a prosthetic heart valve system accordingto another embodiment.

FIGS. 27 and 28 are schematic perspective and side cross sectional viewsof a prosthetic heart valve according to another embodiment.

FIGS. 29A-D are schematic illustrations of stiffness profiles of aprosthetic heart valve according to another embodiment.

FIG. 30A is a side view of an outer frame of a prosthetic heart valvehaving an angled cuff arrangement, in a deployed or biasedconfiguration, according to an embodiment.

FIG. 30B is a schematic cross-sectional side view of the prostheticheart valve shown in FIG. 30A, including an inner valve assembly.

FIG. 30C is a side view of the prosthetic heart valve shown in FIG. 30A,having an angled cuff arrangement and in a deployed or biasedconfiguration, and a side view of a prosthetic heart valve without anangled cuff arrangement, in a deployed or biased configuration.

FIG. 31A is a side view of an outer frame of a prosthetic heart valvehaving a short body portion, in a deployed or biased configuration,according to an embodiment.

FIGS. 31B and 31C illustrate schematic cross-sectional perspective andside views, respectively, of the prosthetic heart valve shown in FIG.31A, including an inner valve assembly.

FIGS. 32A-32C are top views of a prosthetic heart valve having an innervalve assembly radially off-set (FIGS. 32A and 32C) and radiallycentered (FIG. 32B), in a deployed or biased configuration, according toan embodiment.

FIG. 33A is a top view a prosthetic heart valve having an inner valveassembly rotated relative to an A2 segment of an outer frame, in adeployed or biased configuration, according to an embodiment.

FIG. 33B is a bottom view of the inner frame of the prosthetic valve ofFIG. 33A.

FIGS. 34A and 34B illustrate in side view an inner frame of a prostheticheart valve in a compressed and an uncompressed arrangement,respectfully, in a deployed or biased configuration, according to anembodiment.

FIGS. 35A and 35B illustrate in a partial cross-sectional side view andtop view, respectfully, an exemplary prosthetic heart mitral valve in adeployed or biased configuration and seated in a native mitral valveannulus of a heart.

DETAILED DESCRIPTION

Prosthetic heart valves are described herein that can provide clearanceto the LVOT, reduce the possibility of undesirable outflow gradients,and/or limit or prevent LVOT obstructions when implanted in the heart.In some embodiments, a prosthetic heart valve can include an outer framehaving a cuff portion that is disposed at an angle (e.g., 80 degrees)relative to the vertical axis of a body portion of the outer frame, sothat the prosthetic valve can seat securely in the annulus while notobstructing the ventricular outflow tract of the heart. A prostheticheart valve can alternatively, or additionally, include subvalvularcomponents having a short profile, so that the prosthetic valve can seatsecurely in the annulus while not obstructing the ventricular outflowtract of the heart.

A schematic representation of a prosthetic heart valve 100 is shown inFIGS. 1A and 1B. Prosthetic heart valve 100 is designed to replace adamaged or diseased native heart valve such as a mitral valve. Valve 100includes an outer frame assembly 110 and an inner valve assembly 140coupled to the outer frame assembly.

Although not separately shown in the schematic illustration of outerframe assembly 110 in FIGS. 1A and 1B, outer fame assembly 110 may beformed of an outer frame 120, covered on all or a portion of its outerface with an outer covering 130, and covered on all or a portion of itsinner face by an inner covering 132.

Outer frame 120 can provide several functions for prosthetic heart valve100, including serving as the primary structure, as anchoring mechanismand/or an attachment point for a separate anchoring mechanism to anchorthe valve to the native heart valve apparatus, a support to carry innervalve assembly 140, and/or a seal to inhibit paravalvular leakagebetween prosthetic heart valve 100 and the native heart valve apparatus.

Outer frame 120 is preferably formed so that it can be deformed(compressed and/or expanded) and, when released, return to its original(undeformed) shape. To achieve this, outer frame 120 is preferablyformed of materials, such as metals or plastics, that have shape memoryproperties. With regards to metals, Nitinol® has been found to beespecially useful since it can be processed to be austenitic,martensitic or super elastic. Other shape memory alloys, such asCu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may be used.

Outer frame 120 is preferably formed from a laser cut, thin-walled tubeof Nitinol®. The laser cuts form regular cutouts in the thin Nitinol®tube. The tube can be expanded radially, placed on a mold or mandrel ofthe desired shape, heated to the martensitic temperature, and quenched.The treatment of the frame in this manner will form an open latticeframe structure, and may have a flared end or cuff at the atrium endportion 126 of outer frame 120. Outer frame 120 thus has shape memoryproperties and will readily revert to the memory shape at the calibratedtemperature. Alternatively, outer frame 120 may be constructed frombraided wire or other suitable material.

Inner valve assembly 140 is shown schematically in more detail in FIGS.2A-2C. Inner valve assembly 140 can include an inner frame 150, an outercovering 160, and leaflets 170. In the simplified form shownschematically in FIG. 2A, inner frame 150 includes six axial posts orframe members that support outer covering 160 and leaflets 170. Leaflets170 are attached along three of the posts, shown as commissure posts 152in FIG. 2A, and outer covering 160 is attached to the other three posts,154 in FIG. 2A, and optionally to commissure posts 152. In thesimplified form illustrated schematically in FIG. 2A, each of outercovering 160 and leaflets 170 are formed of approximately rectangularsheets of material, which are joined together at their upper, or atriumend. The lower, ventricle end of outer covering 160 may be joined toinner covering 132 of outer frame assembly 110 (not shown in FIG. 2A),and the lower, ventricle end of leaflets 170 may form free edges, thoughcoupled to the lower ends of commissure posts 152.

As shown in FIGS. 2B and 2C, leaflets 170 are movable between an openconfiguration (FIG. 2B) and a closed configuration (FIG. 2C) in whichthe leaflets coapt, or meet in sealing abutment.

At the lower, or ventricle end, leaflets 170 may have a smallerperimeter than outer covering 160. Thus, the free lower edges of theleaflets, between commissure posts 152 (each portion of leaflets 170between adjacent commissure posts being referred to as a “belly” ofleaflets 170) are spaced radially from the lower edge of outer covering160. This radial spacing facilitates movement of the leaflets from theopen position in FIG. 2B to the closed position in FIG. 2C, as thecounter flow of blood from the ventricle to the atrium during systolecan catch the free edges of the bellies and push the leaflets closed.

Outer covering 130 and inner covering 132 of outer frame 120, outercovering 160 and leaflets 170 may be formed of any suitable material, orcombination of materials. In some embodiments, the tissue is optionallya biological tissue, such as a chemically stabilized tissue from a heartvalve of an animal, such as a pig, or pericardial tissue of an animal,such as cow (bovine pericardium), sheep (ovine pericardium), pig(porcine pericardium), or horse (equine pericardium). Preferably, thetissue is bovine pericardial tissue. Examples of suitable tissue includethat used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, allproducts currently used in surgical procedures, and which are marketedas being harvested generally from cattle less than 30 months old.Alternatively, valve leaflets 170 may optionally be made frompericardial tissue or small intestine submucosal (SIS) tissue.

Synthetic materials, such as polyurethane or polytetrafluoroethylene,may also be used for valve leaflets 170. Where a thin, durable syntheticmaterial is contemplated, e.g. for outer covering 130 or inner cover132, synthetic polymer materials such expanded polytetrafluoroethyleneor polyester may optionally be used. Other suitable materials mayoptionally include thermoplastic polycarbonate urethane, polyetherurethane, segmented polyether urethane, silicone polyether urethane,silicone-polycarbonate urethane, and ultra-high molecular weightpolyethylene. Additional biocompatible polymers may optionally includepolyolefins, elastomers, polyethylene-glycols, polyethersulphones,polysulphones, polyvinylpyrrolidones, polyvinylchlorides, otherfluoropolymers, silicone polyesters, siloxane polymers and/or oligomers,and/or polylactones, and block co-polymers using the same.

In another embodiment, valve leaflets 170 may optionally have a surfacethat has been treated with (or reacted with) an anti-coagulant, such as,without limitation, immobilized heparin. Such currently availableheparinized polymers are known and available to a person of ordinaryskill in the art.

As shown in FIGS. 1A, 1B, and 2A, inner valve assembly 140 may besubstantially cylindrical, and outer frame assembly 110 may be tapered,extending from a smaller diameter (slightly larger than the outerdiameter of inner valve assembly 140) at a lower, ventricle portion 112(where it is coupled to inner valve assembly 140) to a larger diameter,atrium portion 116, with an intermediate diameter, annulus portion 114between the atrium and ventricle portions.

A tapered annular space or pocket 185 is thus formed between the outersurface of inner valve assembly 140 and the inner surface of outer frameassembly 110, open to the atrium end of valve assembly 100. When valveassembly 100 is disposed in the annulus of a native heart valve, bloodfrom the atrium can move in and out of pocket 185. The blood can clot,forming thrombus, and the thrombus can be washed out by the flow ofblood during the cyclic pumping of the heart, which is undesirable. Toinhibit such washout of thrombus, and to enhance clotting, ingrowth oftissue into the surfaces of valve 100, and produce other benefits, thepocket can be covered, or enclosed, by a pocket closure 180.

Pocket closure 180 can be formed at least in part of any suitablematerial that is sufficiently porous to allow blood, includingparticularly red blood cells, to enter pocket 185, but is not so porousas to allow undesirably large thrombi to leave the pocket 185, or toallow washout of thrombus formed in the pocket 185. For example, pocketclosure 180 may be formed at least in part from a woven or knitpolyester fabric with apertures less than 160μ, and preferably between90μ and 120μ. It is not necessary for the entirety of pocket closure 180to be formed of the same material, with the same porosity. For example,some portions of pocket closure 180 may be formed of a less porous, orblood impermeable, material and other portions formed of material of theporosity range noted above. It is also contemplated that a portion ofthe outer frame assembly 110 or the inner valve assembly 140 may beformed with an aperture that communicates with pocket 180, covered by aclosure formed of material having the desired porosity, thus providinganother path by which blood may enter, but thrombi are prevented fromleaving, atrial pocket 185.

The outer surface of inner valve assembly 110, and/or the inner surfaceof outer frame assembly 140, need not be circular in cross-section asshown schematically in FIGS. 1A and 1B, but may be of non-constantradius at a given location along the central axis of valve 100. Thus,pocket 185 may not be of constant cross-section, and may not becontinuous, but rather may be formed in two or more fluidicallyisolated, partially annular volumes. Similarly, pocket closure 180 neednot be shaped as a ring with constant width as shown schematically inFIGS. 1A and 1B, but rather can be a continuous ring of varying width, amore complicated continuous shape, or may be formed in multiple,discrete sections.

Pocket closure 180 serves to trap and/or slow the flow of blood withinpocket 185, reducing hemodynamic washout and increasing formation ofthrombus in pocket 185. It also promotes active in-growth of nativetissue into the several coverings of prosthetic heart valve 100, furtherstabilizing valve 100 in the native heart valve. The material formingthe outer covering of inner valve assembly 140 can also be hardened orstiffened, providing better support for leaflets 170. Also, a mass ofthrombus filling pocket 185 can serve as potting for inner valveassembly 140, further stabilizing the valve assembly. Greater stabilityfor inner valve assembly 140 can provide more reliable coaption of valveleaflets 170, and thus more effective performance. The mass of thrombuscan also stabilize the outer frame assembly 110 after it has beeninstalled in, and flexibly conformed to, the native valve apparatus.This can provide a more effective seal between prosthetic heart valve100 and the native valve apparatus, and reduce perivalvular leakage.

One possible implementation of the prosthetic heart valve shownschematically in FIGS. 1A-2C is prosthetic heart valve 200, shown in topview in FIG. 3. Prosthetic heart valve 200 includes an outer frameassembly 210 and an inner valve assembly 240 coupled to the outer frameassembly.

The outer frame assembly 210 includes an outer frame 220, covered on allor a portion of its outer face with an outer covering 230 (not visible),and covered on all or a portion of its inner face by an inner covering232.

The inner valve assembly 240 includes an inner frame 250, an outercovering 260 (not visible), and leaflets 270. Inner frame 250 includessix axial posts or frame members that support outer covering 260 andleaflets 270. The inner valve assembly 240 may be substantiallycylindrical, and outer frame assembly 210 may be tapered, extending froma smaller diameter (slightly larger than the outer diameter of innervalve assembly 240) at a lower, ventricle portion (where it is coupledto inner valve assembly 240) to a larger diameter, atrium portion, withan intermediate diameter, annulus portion between the atrium andventricle portions.

A tapered annular space or pocket 285 (e.g., atrial thrombogenic sealingpocket) is thus formed between the outer surface of inner valve assembly240 and the inner surface of outer frame assembly 210, open to theatrium end of valve assembly 200. The pocket closure 280 can, forexample, be formed from a circular piece of wire, or halo, with apermeable mesh fabric or tissue, that is sewn and thereby connected tothe inner frame 250 and/or to the leaflets 170. The inner frame 250 hasan inner wireframe structure (e.g., made of Nitinol wire) that supportsthe leaflets 270 sewn to the inner frame 250 and functions as a valve.The inner frame 250 in FIG. 3 includes three U-shaped wire componentsjoined at their opened ends to form junctions. Leaflets 270 are sewn tothese components to form articulating leaflets 270 creating andfunctioning as a prosthetic valve (e.g., prosthetic tricuspid valve;prosthetic mitral valve; prosthetic aortic valve, etc.).

Moreover, the inner frame 250 has (tether) attachment apertures 211 (notshown), for attaching tether assembly 290 (not shown). Tether assembly290 is connected to epicardial securing pad 254 (not shown).

In operation, the inner valve assembly 240 is disposed within andsecured within the outer frame assembly 210. Outer frame assembly 210may also have in various embodiments an outer stent tissue material.Outer frame assembly 210 includes an articulating collar 246 which has acollar cover 248. Articulating collar 246 is specifically shaped tosolve leakage issues arising from native structures. In particular,collar 246 is composed of an A2 segment 247, a P2 segment 249, and twocommissural segments, the A1-P1 segment 251, and the A3-P3 segment 253.The collar 246 may also have in preferred embodiments a shortened orflattened or D-shaped section 262 of the A2 segment in order toaccommodate and solve left ventricular outflow tract (LVOT) obstructionissues.

In operation, the prosthetic heart valve 200 may be deployed (e.g., as aprosthetic mitral valve) using catheter delivery techniques. Theprosthetic heart valve 200 is compressed within a narrow catheter anddelivered to the annular region of the native valve (e.g., the leftatrium) with a pre-attached tether assembly 290. There, the valve 200 ispushed out of the catheter where it springs open into its pre-formedfunctional shape without the need for manual expansion (e.g., manualexpansion using an inner balloon catheter). When the valve 200 is pulledinto place, the outer frame assembly 210 is seated in the native mitralannulus, leaving the articulating collar 246 to engage the atrial floorand prevent pull-thru (where the valve 200 is pulled into theventricle). In such embodiments, it is not necessary to cut-away thenative leaflets, as has been taught in prior prosthetic efforts.Instead, the native leaflets can be used to provide a tensioning and/orsealing function around the outer frame assembly 210. It is advantageousfor the valve 200 to be asymmetrically deployed in order to address LVOTproblems where non-accommodating prosthetic valves push against the A2anterior segment of the valve (e.g., mitral valve) and close blood flowthrough the aorta, which anatomically sits immediately behind the A2segment of the mitral annulus. Thus, D-shaped section 262 is deployedsubstantially immediately adjacent/contacting the A2 segment since theflattened D-shaped section 262 is structurally smaller and has a morevertical profile (closer to paralleling the longitudinal axis of theouter frame assembly 212) and thereby provides less pressure on the A2segment. Once the valve 200 is properly seated, tether assembly 290 maybe extended out through the apical region of the left ventricle andsecured using an epicardial pad 254 or similar suture-locking attachmentmechanism (not shown).

In an alternate embodiment, the tether assembly 290 is on the outerframe assembly 210, which would then have (tether) attachment apertures213 for attaching tether assembly 290 to epicardial securing pad 254.

FIG. 4 is a top, or atrial, view of another embodiment of a prostheticheart valve 300, illustrated without pocket closure 380. FIG. 4 showsthe top of the junction tip 302 of the three U-shaped wire components ofinner frame 350 joined at their opened ends to form junctions 302.Leaflets 370 are sewn to these components to form articulating leaflets370 creating and functioning as a prosthetic valve (e.g., prosthetictricuspid valve, prosthetic mitral valve, prosthetic aortic valve,etc.). Thrombogenic pocket 385 is shown below the plane of the collar.FIG. 4 shows vertical A2 segment 347, the P2 segment 349, and thecommissural A1-P1 segment 351 and A3-P3 segment 353. FIG. 4 shows howupon deployment blood would fill the void or gap 385 between the innervalve assembly 340 and the outer frame assembly 310 of the valve 300.This blood creates a temporary fluid seal that pools in that space andprovide a pressure buffer against the leakage inducing forces thataccompany systolic and diastolic related intra-atrial andintra-ventricular pressure. Moreover, FIG. 4 provides an illustration ofcollar 346 that may, in some embodiments, include a shortened orflattened or D-shaped section 362 of the A2 segment in order toaccommodate and solve left ventricular outflow tract (LVOT) obstructionissues.

FIG. 5 is a perspective side view of the P2 area 447 and A3-P3 area 453of a self-expanding pre-configured compressible transcatheter prostheticcardiovascular valve 400 contemplated herein, that contains as asub-component, a self-expanding inner valve assembly 440. The valve 400further includes as a sub-component, an outer frame assembly 410. Theouter frame assembly 410 and the inner valve assembly 440 collectivelydefine thrombogenic pockets 485. FIG. 5 shows one of the three U-shapedwire components of inner frame 450 joined at their opened ends to formjunctions 402. Leaflets 470 are sewn to these components to formarticulating leaflets 470 creating and functioning as a prostheticvalve. Thrombogenic pocket 485 is shown slightly below the plane of themajority of collar 446 except for the vertical A2 segment 447, the P2segment 449, and the commissural A1-P1 segment 451 (not shown) and A3-P3segment 453. FIG. 5 shows how upon deployment blood would fill the voidor gap (i.e., pocket 485) between the inner valve assembly 440 and theouter frame assembly 410 at the A3-P3 segment 453 area of the valve 400.This blood creates a temporary fluid seal that would pool in that spaceand provide a pressure buffer against the leakage inducing forces thataccompany systolic and diastolic related intra-atrial andintra-ventricular pressure.

FIG. 6 is an exploded view of an embodiment of the pre-configuredcompressible transcatheter prosthetic cardiovascular valve 400, whichcontains as a sub-component, a self-expanding inner frame 450. The valve400 further includes as a sub-component, an outer frame assembly 410.The outer frame assembly 410 and the inner valve assembly 440collectively define thrombogenic pockets 485 (not shown). The pocket 485is formed between inner valve assembly 440, as the inside of theV-shaped or U-shaped pocket, and the outer frame assembly 410 with outercovering 430, as the outside of the V-shaped or U-shaped pocket. In thisvalve 400, the inner valve assembly 440 has an atrial thrombogenicsealing pocket closure 480 (not shown) (e.g., formed from a circularpiece of wire, or halo), with a permeable mesh fabric or tissue, that issewn and thereby connected to the inner frame 450 and/or to the leaflets470. The inner frame 450 includes an inner wireframe structure made ofNitinol wire that supports leaflets 470 sewn to the inner frame 450 andfunctions as a valve. The inner frame 450 includes three main U-shapedwire components 407 joined at their opened ends to form junctions 402.Optionally, in some embodiments, the inner frame 450 can includeadditional wire cross-members or struts (e.g., more than three).

In this valve 400, the inner frame 450 is sewn with tissue and acts acover to prevent valvular leakage. The inner valve assembly 440 includesthe leaflets 470. The leaflets 470 include articulating leaflets thatdefine a valve function. The leaflets 470 are sewn to the inner frame450. The inner frame 450 also has (tether) attachment apertures 411 forattaching tether assembly 490. Tether assembly 490 is shown in thisexample as connected to epicardial securing pad 454. In operation, thecovered inner valve assembly 440 (with leaflets 470), is disposed withinand secured within the outer frame assembly 410. Outer frame assembly410 may also have in various embodiments an outer covering 460. Outerframe assembly 410 has an articulating collar 446 which has a collarcover 448. Articulating collar 446 may also have in preferredembodiments a flattened or D-shaped section 462 at the A2 area toaccommodate and solve left ventricular outflow tract (LVOT) obstructionissues. Collar 446 may also have specially formed commissural segmentsto prevent commissural leakage at A1-P1 segment 451 and at A3-P3 segment453

In operation, the valve 400 may be deployed as a prosthetic valve usingcatheter delivery techniques. The valve 400 is compressed within anarrow catheter and delivered to the annular region of the native valve(e.g., the left atrium) with a pre-attached tether assembly 490. There,the valve 400 is pushed out of the catheter where it springs open intoits pre-formed functional shape without the need for manual expansion(e.g., manual expansion using an inner balloon catheter). When the valve400 is pulled into place, the outer frame assembly 410 is seated in thenative annulus (e.g., native mitral annulus), leaving the articulatingcollar 446 to engage the atrial floor and prevent pull-thru (where thevalve is pulled into the ventricle). In such embodiments, it is notnecessary to cut-away the native leaflets, as has been taught in priorprosthetic efforts. Instead, the native leaflets can be used to providea tensioning and/or sealing function around the valve 400 (e.g., aroundthe outer frame assembly 410). It is advantageous for the valve 400 tobe asymmetrically deployed in order to address LVOT problems wherenon-accommodating prosthetic valves push against the A2 anterior segmentof the valve (e.g., the mitral valve) and close blood flow through theaorta, which anatomically sits immediately behind the A2 segment of theannulus (e.g., mitral annulus).

Thus, D-shaped section 462 is deployed substantially immediatelyadjacent/contacting the A2 segment since the flattened D-shaped section462 is structurally smaller and has a more vertical profile (closer toparalleling the longitudinal axis of the outer frame assembly 410) andthereby provides less pressure on the A2 segment. Once the valve 400 isproperly seated, tether assembly 490 may be extended out through theapical region of the left ventricle and secured using an epicardial pad454 or similar suture-locking attachment mechanism.

FIGS. 7-9 are front, bottom, and top views, respectively, of aprosthetic heart valve 500 according to an embodiment.

Prosthetic heart valve 500 is designed to replace a damaged or diseasednative heart valve such as a mitral valve. Valve 500 includes an outerframe assembly 510 and an inner valve assembly 540 coupled to the outerframe assembly 510.

As shown, outer frame assembly 510 includes an outer frame 520, coveredon all or a portion of its outer face with an outer covering 530, andcovered on all or a portion of its inner face by an inner covering 532.

Outer frame 520 can provide several functions for prosthetic heart valve500, including serving as the primary structure, as anchoring mechanismand/or an attachment point for a separate anchoring mechanism to anchorthe valve to the native heart valve apparatus, a support to carry innervalve assembly 540, and/or a seal to inhibit paravalvular leakagebetween prosthetic heart valve 500 and the native heart valve apparatus.

Outer frame 520 is configured to be manipulated and/or deformed (e.g.,compressed and/or expanded) and, when released, return to its original(undeformed) shape. To achieve this, outer frame 520 can be formed ofmaterials, such as metals or plastics, that have shape memoryproperties. With regards to metals, Nitinol® has been found to beespecially useful since it can be processed to be austenitic,martensitic or super elastic. Other shape memory alloys, such asCu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may be used.

As best shown in FIG. 7, outer frame assembly 510 has an upper end(e.g., at the atrium portion 516), a lower end (e.g., at the ventricleportion 512), and a medial portion (e.g., at the annulus portion 514)therebetween. The medial portion of the outer frame assembly 510 has aperimeter that is configured (e.g., sized, shaped) to fit into anannulus of a native atrioventricular valve. The upper end of the outerframe assembly 510 has a perimeter that is larger than the perimeter ofthe medial portion. In some embodiments, the perimeter of the upper endof the outer frame assembly 510 has a perimeter that is substantiallylarger than the perimeter of the medial portion. As shown best in FIG.9, the upper end and the medial portion of the outer frame assembly 510has a D-shaped cross-section. In this manner, the outer frame assembly510 promotes a suitable fit into the annulus of the nativeatrioventricular valve.

Inner valve assembly 540 includes an inner frame 550, an outer covering560, and leaflets 570. As shown, the inner valve assembly 540 includesan upper portion having a periphery formed with multiple arches. Theinner frame 550 includes six axial posts or frame members that supportouter covering 560 and leaflets 570. Leaflets 570 are attached alongthree of the posts, shown as commissure posts 552 (best illustrated inFIG. 8), and outer covering 560 is attached to the other three posts,554 (best illustrated in FIG. 8), and optionally to commissure posts552. Each of outer covering 560 and leaflets 570 are formed ofapproximately rectangular sheets of material, which are joined togetherat their upper, or atrium end. The lower, ventricle end of outercovering 560 may be joined to inner covering 532 of outer frame assembly510, and the lower, ventricle end of leaflets 570 may form free edges575, though coupled to the lower ends of commissure posts 552.

Although inner valve assembly 540 is shown as having three leaflets, inother embodiments, an inner valve assembly can include any suitablenumber of leaflets. The leaflets 570 are movable between an openconfiguration and a closed configuration in which the leaflets 570coapt, or meet in a sealing abutment.

At the lower, or ventricle end, leaflets 570 may have a smallerperimeter than outer covering 560. Thus, the free lower edges of theleaflets, between commissure posts 552 (each portion of leaflets 570between adjacent commissure posts being referred to as a “belly” ofleaflets 570) are spaced radially from the lower edge of outer covering560 of the inner valve assembly 540. This radial spacing facilitatesmovement of the leaflets 570 from the open position to the closedposition as the counterflow of blood from the ventricle to the atriumduring systole can catch the free edges of the bellies and push theleaflets 570 closed (e.g., coapt).

Outer covering 530 of the outer frame assembly 510 and inner covering532 of outer frame assembly 510, outer covering 560 of the inner valveassembly 540 and leaflets 570 of the inner valve assembly 540 may beformed of any suitable material, or combination of materials, such asthose discussed above. In this embodiment, the inner covering 532 of theouter frame assembly 510, the outer covering 560 of the inner valveassembly 540, and the leaflets 570 of the inner valve assembly 540 areformed, at least in part, of porcine pericardium. Moreover, in thisembodiment, the outer covering 530 of the outer frame assembly 510 isformed, at least in part, of polyester.

In another embodiment, valve leaflets 570 may optionally have a surfacethat has been treated with (or reacted with) an anti-coagulant, such as,without limitation, immobilized heparin. Such currently availableheparinized polymers are known and available to a person of ordinaryskill in the art.

Inner valve assembly 540 is substantially cylindrical, and outer frameassembly 510 is tapered, extending from a smaller diameter (slightlylarger than the outer diameter of inner valve assembly 540) at a lower,ventricle portion 512 (where it is coupled to inner valve assembly 540)to a larger diameter, atrium portion 516, with an intermediate diameter,annulus portion 514 between the atrium and ventricle portions.

As shown, a tapered annular space or pocket 585 is thus formed betweenthe outer surface of inner valve assembly 540 and the inner surface ofouter frame assembly 510, open to the atrium end of valve assembly 500.As shown, pocket closure 580 is coupled along the periphery of the upperend of the inner valve assembly 540. In some embodiments, the pocketclosure 580, or a portion thereof, can be coupled along any suitableportion of the inner valve assembly 540.

As discussed above, pocket closure 580 can be formed at least in part ofany suitable material that is sufficiently porous to allow blood,including particularly red blood cells, to enter pocket 585, but is notso porous as to allow undesirably large thrombi to leave the pocket 585,or to allow washout of thrombus formed in the pocket 585. In thisembodiment, pocket closure 580 is formed entirely of knit polyester(i.e., PET warp knit fabric) having apertures of about 90-120 microns.In some embodiments, a pocket closure can include apertures less thanabout 160 microns.

Inner frame 550 is shown in more detail in FIGS. 10-12. Specifically,FIGS. 10-12 show inner frame 550 in an undeformed, initial state (FIG.10), a side view of the inner frame 550 in a deployed configuration(FIG. 11), and a bottom view of the inner frame 550 in a deployedconfiguration (FIG. 12), respectively, according to an embodiment.

In this embodiment, inner frame 550 is formed from a laser-cut tube ofNitinol®. Inner frame 550 is illustrated in FIG. 10 in an undeformed,initial state, i.e. as laser-cut, but cut and unrolled into a flat sheetfor ease of illustration. Inner frame 550 can be divided into fourportions, corresponding to functionally different portions of the innerframe 550 in final form: atrial portion 541, body portion 542, strutportion 543, and tether clamp portion 544. Strut portion 543 includessix struts, such as strut 543A, which connect body portion 542 to tetherclamp portion 544.

Connecting portion 544 includes longitudinal extensions of the struts,connected circumferentially by pairs of opposed, slightly V-shapedconnecting members (or “micro-Vs”). Connecting portion 544 is configuredto be radially collapsed by application of a compressive force, whichcauses the micro-Vs to become more deeply V-shaped, with the verticesmoving closer together longitudinally and the open ends of the V shapesmoving closer together circumferentially. Thus, connecting portion 544can be configured to compressively clamp or grip one end of a tether,either connecting directly onto a tether line (e.g. braided filamentline) or onto an intermediate structure, such as a polymer or metalpiece that is in turn firmly fixed to the tether line.

In contrast to connecting portion 544, atrial portion 541 and bodyportion 542 are configured to be expanded radially. Strut portion 543forms a longitudinal connection, and radial transition, between theexpanded body portion and the compressed connecting portion 544.

Body portion 542 includes six longitudinal posts, such as post 542A. Theposts can be used to attach leaflets 570 to inner frame 540, and/or canbe used to attach inner assembly 540 to outer assembly 510, such as byconnecting inner frame 550 to outer frame 520. In the illustratedembodiment, the posts include openings through which connecting members(such as suture filaments and/or wires) can be passed to couple theposts to other structures.

Inner frame 550 is shown in a fully deformed, i.e. to the final,deployed configuration, in side view and bottom view in FIGS. 11 and 12,respectively.

Outer frame 520 of valve 500 is shown in more detail in FIGS. 13-15. Inthis embodiment, outer frame 520 is also formed from a laser-cut tube ofNitinol®. Outer frame 520 is illustrated in FIG. 13 in an undeformed,initial state, i.e. as laser-cut, but cut and unrolled into a flat sheetfor ease of illustration. Outer frame 520 can be divided into a couplingportion 571, a body portion 572, and a cuff portion 573, as shown inFIG. 13.

Coupling portion 571 includes multiple openings or apertures, such as571A, by which outer frame 520 can be coupled to inner frame 550, asdiscussed in more detail below.

Outer frame 520 is shown in a fully deformed, i.e. to the final,deployed configuration, in side view and top view in FIGS. 14 and 15,respectively. As best seen in FIG. 15, the lower end of coupling portion571 forms a roughly circular opening (identified by “O” in FIG. 15). Thediameter of this opening preferably corresponds approximately to thediameter of body portion 542 of inner frame 550, to facilitate couplingof the two components of valve 500.

Outer frame 520 and inner frame 550 are shown coupled together in FIGS.16-18, in front, side, and top views, respectively. The two framescollectively form a structural support for a prosthetic valve such asvalve 500. The frames support the valve leaflet structure (e.g.,leaflets 570) in the desired relationship to the native valve annulus,support the coverings (e.g., outer covering 530, inner covering 532,outer covering 560) for the two frames to provide a barrier to bloodleakage between the atrium and ventricle, and couple to the tether(e.g., tether assembly 590) (by the inner frame 550) to aid in holdingthe prosthetic valve in place in the native valve annulus by the tetherconnection to the ventricle wall. The outer frame 520 and the innerframe 550 are connected at six coupling points (representative pointsare identified as “C”). In this embodiment, the coupling points areimplemented with a mechanical fastener, such as a short length of wire,passed through an aperture (such as aperture 571A) in coupling portion571 of outer frame 520 and corresponding openings in longitudinal posts(such as post 542A) in body portion 542 of inner frame 550. Inner frame550 is thus disposed within the outer frame 520 and securely coupled toit.

A template 534 (or design pattern) for cutting, shaping, and sizingouter covering 530 of outer frame assembly 510 and/or inner covering 532of outer frame assembly is illustrated in FIG. 19, according to anembodiment. Design pattern 534 includes attachment location indications536 a, 536 b. To arrange outer covering 530 into an assembledconfiguration (i.e., either coupled to or ready to be coupled to outerframe 520), the two ends of the outer covering 530 are coupled together(e.g., sewn) in accordance with the attachment location indications 536a, 536 b of the template 534. Similarly, inner covering 532 is arrangedinto an assembled configuration by coupling (e.g., sewing) its endstogether in accordance with the attachment location indications 536 a,536 b.

FIG. 20 illustrates a design pattern of one leaflet 570 and associatedportion of outer covering 560 of the inner valve assembly in itsinitial, pre-assembled state (i.e., not attached to inner frame 550),according to an embodiment. As discussed above, the portion of leaflet570 between adjacent commissure posts is referred to as a “belly” of theleaflet 570. The belly has a curved edge indicated with reference ‘B’ inFIG. 20. During assembly of inner valve assembly 540, the leaflet 570 iscoupled to the inner frame 550 of the inner valve assembly 540.Specifically, the belly edge B of the leaflet 570, or a portion thereof,is coupled to the inner frame 550 at the arch portion of the inner frame550. In addition, outer covering 560 is folded over a portion of theinner frame 550 (e.g., the arch portion) along the axis indicated with‘F’, and coupled to a portion of the inner frame 550 (e.g., thecommissure post 552) along attachment line A. As shown, a coupling areaC (e.g., a stitching area), is disposed outside and adjacent toattachment line A. Coupling area C can facilitate the assembly process.Subsequently, excess leaflet material and/or excess outer coveringmaterial can be cut away and disposed of or reused. For example,material disposed between the belly edge B and the F-axis, or materialin the coupling area C, may, in some embodiments, be unnecessarymaterial and thus can be cut away from the leaflet 570 and/or outercovering 560. The assembly process can be repeated for each leaflet 570,each outer covering 560, and each commissure post 552.

The leaflets 570 and the outer covering 560 can have any suitable size,shape, material, and/or configuration. For example, in this embodiment,leaflets 570 and/or outer covering 560 is formed of fixed porcinepericardium, with a thickness of about 0.01 inches.

A schematic representation of another embodiment of a prosthetic heartvalve is shown in FIGS. 21 and 22. Prosthetic heart valve 600 isdesigned to replace a damaged or diseased native heart valve such as amitral valve. Valve 600 includes an outer frame assembly 610 and aninner valve assembly 640 coupled to the outer frame assembly 610.

Although not separately shown in the schematic illustration of outerframe assembly 610 in FIGS. 21 and 22, outer frame assembly 610 may beformed of an outer frame 620, covered on all or a portion of its outerface with an outer covering 630, and covered on all or a portion of itsinner face by an inner covering 632. The materials and construction ofthe components of prosthetic heart valve 600 can be similar to those ofthe other embodiments described above. The following discussion focuseson the aspects of this embodiment that differ from the previousembodiments.

Inner valve assembly 640 includes an inner frame 650 (not shown), anouter covering 660 (not shown), leaflets 670 (not shown), and atrialstructure 655 (e.g., halo). As shown, the halo 655 is disposed at theatrium portion 616 of inner valve assembly 640. In such a configuration,when valve 600 is implanted into a heart of a patient, halo 655 will bedisposed above the atrial floor and/or native valve annulus of thepatient's heart. In this manner, the halo 655 provides extendedfunctionality (e.g., above the native mitral valve annulus) of the innerframe 650. In some instances, for example, if prosthetic leaflets areseated too low relative to the native valve annulus, the leaflets mayimproperly coapt (e.g., incomplete coaptation) and/or hemodynamicleakage can occur. Thus, disposing halo 655 above the native valveannulus can provide for and/or promote complete coaptation.

Halo 655 can be formed from any suitable method and material. Forexample, in some embodiments, halo 655 can be formed from asubstantially circular piece of wire. In such embodiments, halo 655 canbe coupled to (e.g., sewn) to inner frame 650.

Outer covering 630 and inner covering 632 of outer frame 620, outercovering 660 and leaflets 670 may be formed of any suitable material, orcombination of materials, such as those discussed above in connectionwith other embodiments.

As shown in FIGS. 21 and 22, inner valve assembly 640 may besubstantially cylindrical, and outer frame assembly 610 may be tapered,extending from a smaller diameter (slightly larger than the outerdiameter of inner valve assembly 640) at a lower, ventricle portion 612(where it is coupled to inner valve assembly 640) to a larger diameter,atrium portion 616, with an intermediate diameter, annulus portion 614between the atrium and ventricle portions.

In some embodiments, the outer surface of inner valve assembly 610,and/or the inner surface of outer frame assembly 640, need not becircular in cross-section as shown schematically in FIGS. 21 and 22, butmay be of non-constant radius at a given location along the central axisof valve 600.

The atrial halo 655 functions by extending the inner frame of an innervalve assembly above the plane of atrial floor in an improved prostheticheart valve that includes an inner frame that holds the leaflets andwhich is disposed within an outer frame for reducing or preventingleaking when the prosthetic heart valve is disposed within a heart valve(e.g., mitral valve, tricuspid valve).

A benefit to having leaflets within a raised leaflet silo or cylinder(e.g., halo 650) is improved blood flow and leaflet closure. It has beenobserved that where the leaflet cylinder is at the atrial floor, leafletcoaptation is incomplete and can result in hemodynamic leakage.

Accordingly, by providing an atrial halo or ring structure that israised above the plane of the native annulus or atrial floor, completeleaflet coaptation is encouraged. During ventricular contraction orsystole, the blood is ejected towards the aortic valve to exit the heartbut is also ejected towards the prosthetic mitral valve, which needs toremain closed during systole. Retrograde blood hitting the prostheticvalve leaflets cause the leaflets to close, preventing regurgitationinto the left atrium. During diastole or ventricular filling, the bloodneeds to flow from the atrium into the ventricle without obstruction.However, when prosthetic leaflets are not properly placed or properlyaligned, the leaflets can obstruct efficient filling of the ventricle orcause uneven ventricular output.

FIG. 23 is a top-view of a prosthetic heart valve 700 according to anembodiment that is one possible implementation of the prosthetic heartvalve shown schematically in FIGS. 21 and 22. Prosthetic heart valve 700includes an outer frame assembly 710, an inner valve assembly 740, and atether assembly 790. The inner valve assembly 740 includes an innerframe 750, and outer covering 760 (not shown), leaflets 770, and atrialstructure 755 (e.g., halo). Halo 755 can be formed from a circular pieceof wire that can be connected to the inner frame 750 and sewn to theleaflets 770. The inner frame 750 can be made of Nitinol® wire thatsupports leaflets 770 sewn to the inner frame 750 and functions as avalve. The inner frame 750 shown in FIG. 23 includes three U-shaped wirecomponents joined at their opened ends to form junctions 702. Leaflets770 are sewn to these components to form articulating leaflets, creatingand functioning as a prosthetic valve (e.g., prosthetic mitral valve,prosthetic tricuspid valve).

In some embodiments, the inner frame 750 has tether attachment apertures711 (not shown) for attaching tether assembly 790. Tether assembly 790is connected to epicardial securing pad 754 (not shown).

In operation, the inner frame 750 (with leaflets 770), is disposedwithin and secured within the outer frame 720 of the outer frameassembly 710. Outer frame 720 includes an outer covering 730 (not shown)(e.g., tissue material) and an inner covering 732 (e.g., tissuematerial). Outer frame 720 has an articulating collar 746 which has acollar cover 748. Articulating collar 746 is configured (e.g., shapedand sized) to solve leakage issues arising from native structures. Inparticular, collar 746 is composed of an A2 segment 747, a P2 segment749, and two commissural segments, the A1-P1 segment 751, and the A3-P3segment 753. The collar 746 may also have, in some embodiments ashortened or flattened or D-shaped section 762 of the A2 segment inorder to accommodate and solve left ventricular outflow tract (LVOT)obstruction issues.

In operation, the valve 700 may be deployed as a prosthetic mitral valveusing catheter delivery techniques. The entire valve 700 is compressedwithin a narrow catheter and delivered to the annular region of thenative valve, preferably the left atrium, with a pre-attached tetherapparatus. Upon delivery, the valve 700 is pushed out of the catheterwhere it springs open into its pre-formed functional shape without theneed for manual expansion (e.g., manual expansion using an inner ballooncatheter). When the valve 700 is pushed and/or pulled into place, theouter frame assembly 710 is seated in the native valve annulus (e.g.,native mitral annulus), leaving the articulating collar 746 to engagethe atrial floor and prevent pull-through (where the valve is pulledinto the ventricle). In such embodiments, it is not necessary tocut-away the native leaflets, as has been taught in prior prostheticefforts. Instead, the native leaflets can be used to provide atensioning and/or sealing function around the outer frame assembly 710.It is advantageous for the valve 700 to be asymmetrically deployed inorder to address LVOT problems where non-accommodating prosthetic valvespush against the A2 anterior segment of the valve (e.g., mitral valve)and close blood flow through the aorta, which anatomically sitsimmediately behind the A2 segment of the mitral annulus. Thus, D-shapedsection 762 is deployed substantially immediately adjacent/contactingthe A2 segment since the flattened D-shaped section 762 is structurallysmaller and has a more vertical profile (closer to paralleling thelongitudinal axis of the outer stent) and thereby provides less pressureon the A2 segment. Once the valve 700 is properly seated, tetherassembly 790 may be extended out through the apical region of the leftventricle and secured using an epicardial pad 754 or similarsuture-locking attachment mechanism (not shown).

In an alternate embodiment, the tether assembly 790 is on the outerframe 720, which would then have tether attachment apertures 713 forattaching tether assembly 790 to epicardial securing pad 754.

FIG. 24 is a perspective view of the A1-P1 side of the prosthetic heartvalve 700 according to an embodiment. FIG. 24 shows one of the threeU-shaped wire components of inner frame 750 joined at their opened endsto form junctions 702. Although three U-shaped wire components areshown, in other embodiments, any suitable number of U-shaped wirecomponents can be joined at their opened ends to form junctions.Similarly, in some embodiments, the wire components of inner frame 750can be any suitable shape or size. Leaflets 770 are sewn to thesecomponents to form articulating leaflets 770 creating and functioning asa prosthetic heart valve (e.g., mitral valve, tricuspid valve). Atrialhalo 755 is shown with the plane of the circular wire above the plane ofthe majority of collar except for the vertical A2 segment 747, the P2segment 749, and the commissural A1-P1 segment 751 an A3-P3 segment 753.FIG. 26 shows how upon deployment blood would fill the void or gap 707between the inner frame 750 and the outer frame 720 at the A1-P1 segment751 of the valve 700. This blood creates a temporary fluid seal thatwould pool in that space and provide a pressure buffer against theleakage inducing forces that accompany systolic and diastolic relatedintra-atrial and intra-ventricular pressure.

FIG. 25 is a perspective view of the A3-P3 side 753 of prosthetic heartvalve 700 according to an embodiment. FIG. 25 shows one of the threeU-shaped wire components of inner frame 750 joined at their opened endsto form junctions 702. Leaflets 770 are sewn to these components to formarticulating leaflets 770 creating and functioning as a prosthetictricuspid valve. Atrial halo 755 is shown with the plane of the circularwire above the plane of the majority of collar except for the verticalA2 segment 747, the P2 segment 749, and the commissural A1-P1 segment751 and A3-P3 segment 753. FIG. 25 shows how upon deployment blood wouldfill the void or gap 708 between the inner frame 750 and outer frame 720at the A3-P3 segment 753 area of the valve 700. This blood creates atemporary fluid seal that would pool in that space and provide apressure buffer against the leakage inducing forces that accompanysystolic and diastolic related intra-atrial and intra-ventricularpressure.

FIG. 26 is an exploded view of prosthetic heart valve 700 according toan embodiment. In this valve 700, the inner frame 750 is sewn withtissue 706 and acts a cover to prevent valvular leakage. The inner frame750 contains the leaflets 770 comprised of articulating leaflets thatdefine a valve function. The leaflets 770 are sewn to the inner frame750. The inner frame 750 also has tether attachment apertures 711 forattaching tether assembly 790. Tether assembly 790 is shown in thisexample as connected to epicardial securing pad 754. In operation, thecovered inner frame 750 (e.g., covered with outer covering 760) (withleaflets 770), is disposed within and secured within the outer frame 720of the outer frame assembly 710. Outer frame 720 may also have invarious embodiments a covering (e.g., outer covering 730). Outer frame720 has an articulating collar 746 which has a collar cover 748.Articulating collar 746 may also have in some embodiments a D-shapedsection 762 to accommodate and solve left ventricular outflow tract(LVOT) obstruction issues.

In operation, the valve 700 may be deployed as a prosthetic valve (e.g.,mitral valve) using catheter delivery techniques. The entire valve 700is compressed within a narrow catheter and delivered to the annularregion of the native valve, such as, for example, with a pre-attachedtether assembly 790. There, the valve 700 is pushed out of the catheterwhere it springs open into its pre-formed functional shape without theneed for manual expansion (e.g., manual expansion using an inner ballooncatheter). When the valve 700 is pushed and/or pulled into place, theouter frame assembly 710 is seated in the native mitral annulus, leavingthe articulating collar 746 to engage the atrial floor and preventpull-through (where the valve is pulled into the ventricle). In suchembodiments, it is not necessary to cut-away the native leaflets, as hasbeen taught in prior prosthetic efforts. Instead, the native leafletscan be used to provide a tensioning and/or sealing function around theouter frame assembly 710. It is advantageous for the valve 700 to beasymmetrically deployed in order to address LVOT problems wherenon-accommodating prosthetic valves push against the A2 anterior segmentof the valve (e.g., the mitral valve) and close blood flow through theaorta, which anatomically sits immediately behind the A2 segment of themitral annulus. Thus, D-shaped section 762 is deployed immediatelyadjacent/contacting the A2 segment since the flattened D-shaped section762 is structurally smaller and has a more vertical profile (closer toparalleling the longitudinal axis of the outer stent) and therebyprovides less pressure on the A2 segment. Once the valve 700 is properlyseated, tether assembly 790 may be extended out through the apicalregion of the left ventricle and secured using an epicardial pad 754 orsimilar suture-locking attachment mechanism.

Any of the prosthetic heart valve embodiments described above canincorporate additional structural features to enhance their performance.The structural features are discussed below with reference to prostheticheart valve 800, illustrated schematically in perspective and side viewsin FIGS. 27 and 28, respectively.

As shown, the outer frame 820 has an atrium portion 826, a ventricleportion 822, and an annulus portion 824 disposed between the atriumportion 826 and the ventricle portion 822. The inner frame 850 of theinner valve assembly 840 has a first end and a second end. The innervalve assembly 840 can be coupled to the outer frame 820 by a connectionbetween the first end of the inner frame 850 and the ventricle portion812 of the outer frame assembly 810. The inner frame assembly 840 canextend from the connection towards the atrium portion 816 of the outerframe assembly 810. The inner frame assembly 840 and the outer frameassembly 810 can diverge from the connection towards the atrium portion816 of the outer frame assembly 810. The annulus portion 814 of theouter frame assembly 810 can be spaced radially from the inner valveassembly 840 and radially inwardly deflectable towards the inner valveassembly 840 to accommodate a natural heart valve annulus in the annulusportion 814.

The outer frame assembly 810 can be shaped and sized in any suitablemanner to facilitate a proper fit into a native heart valve. Forexample, as shown, the outer frame 820 can be shaped and sized toresemble, at least in part, an hourglass shape. Specifically, theannulus portion 814 of outer frame assembly 810 varies from anintermediate diameter (or perimeter) near ventricle portion 812 to asmaller diameter (or perimeter) near the middle of annulus portion 814,to a larger diameter (or perimeter) near atrium portion 816. Thus,annulus portion 814 has an hourglass shape. Ventricle portion 812 has amaximum diameter larger than a maximum diameter of annulus portion 816.The ventricle portion has a minimum diameter smaller than a minimumdiameter of the annulus portion 814.

The diameters and/or perimeters for each portion of the outer frame 820can be selected based on the size and/or shape of a native heart valveinto which prosthetic heart valve 800 is to be implanted. For example,the minimum diameter of the annulus portion 824 of the outer frame 820can be smaller than that of the native valve annulus. Thus, in such aconfiguration, the diameters of the ventricle portion 822, annulusportion 824, and atrium portion 826 can collectively promote a suitablefit (e.g., a snug, secure fit) of the prosthetic heart valve 800 in anative heart valve. In this manner, the outer frame 820 can beconfigured to optimize securement and sealing between the prostheticheart valve 800 (particularly outer frame assembly 810) and a nativevalve annulus of a native heart valve. Thus, such a configurationminimizes the likelihood of paravalvular leaks.

Although the outer frame 820 is shown to have a circular cross-section,in some embodiments, the outer frame 820 can by any suitable shape orsize. For example, in some embodiments, the outer frame 820 can have aD-shape cross-section. In this manner, the outer frame 820 can have ashape configured to correspond to (e.g., mate with) a native heart valveannulus.

In addition to, or instead of, outer frame 820 and/or outer frameassembly 810 with the hourglass shape described above, valve 800, or insome instances, outer frame 820 and/or outer frame assembly 810, inparticular, can be formed to provide stiffness, such as resistance tohoop compression, that is varied spatially, i.e., axially and/orcircumferentially.

In this manner, a suitable stiffness profile can be arranged such thatthe valve 800 promotes a desirable shape and sealing region whendisposed in a native heart valve, thus minimizing the likelihood ofparavalvular leaks and undesired movement of the valve. Similarlystated, valve 800 can be configured to have a stiffness profile suitableto cause desirable deformation of the native heart valve annulus (i.e.,the sealing region), and thus, proper implantation of valve 800.

A desired stiffness profile of prosthetic valve 800 can be achieved byvarying properties, characteristics, and/or the arrangement of the outerframe assembly 810 and the inner valve assembly 840. For example, theouter frame 820 and/or the inner frame 850 can contain portions ofvarying material states. For example, a first portion of outer frame 820can be in an elastic state, while a second portion of outer frame 820 isin a super-elastic state. Similarly, for example, portions of the outerframe 820 and/or the inner frame 850 can be in an austenitic stateand/or a martensitic state (e.g., a stress induced martensitic state).In this manner, portions of valve 800 can be configured to suitably matewith a native valve annulus, thus improving sealing and limitingparavalvular leaks.

In addition, the outer frame assembly 810 and/or inner valve assembly840 can have varying widths, thicknesses, shapes (e.g., longitudinalshape), angles (e.g., angle of attachment between inner valve assembly840 and outer frame assembly 810), and the like. In some embodiments,the outer covering 830, inner covering 832, outer covering 860, and/orpocket closure 880 can be configured to determine, at least in part, thestiffness profile and/or shape of valve 800 (e.g., based on sewingpattern).

FIGS. 29B, and 29C and 29D illustrate axial and circumferentialstiffness profiles, respectively, of prosthetic heart valve 800 (shownin FIG. 29A) according to an embodiment. The stiffness of heart valve800 can vary axially and/or circumferentially in any suitable manner.For example, FIG. 29B represents an axial stiffness profile of valve800. Specifically, as shown, the Z-axis represents an axial location onvalve 800 (e.g., a location of the stiffness value). The S-axisrepresents a range of stiffness (or range of stiffness values),increasing from left (starting at origin O) to right.

Further to this example, as illustrated in FIG. 29B, in someembodiments, locations near the ventricle portion 822 (e.g., indicatedas B in FIG. 29A) of the outer frame 822 can have a larger stiffnessvalue, locations near the annulus portion 824 of the outer frame 820 canhave a smaller stiffness value relative to the ventricle portion 822(e.g., to facilitate cooperation with the native valve annulus), andlocations near the atrium portion 826 (e.g., indicated as A in FIG. 29A)of the outer frame 820 can have a smaller, the same, or larger stiffnessvalue (illustrated by the dotted line) than the stiffness value near theannulus portion 824. In this manner, the outer frame assembly 810 can berelatively more compliant in hoop compression in a central, annulusportion 814, than at the ventricle portion 812. Thus, in use, theprosthetic valve 800 can seat securely in the annulus of the nativeheart valve while imposing minimal loads on the inner valve assembly 840that could degrade the performance of the valve leaflets 870. Although,for ease of illustration, the stiffness profile shown in FIG. 29Bincludes linear portions, in some embodiments, the stiffness profile caninclude non-linear portions instead of or in addition to the linearportions as shown.

Similarly, the stiffness of heart valve 800, or portions of heart valve800, can have varying degrees of stiffness circumferentially, asillustrated by the stiffness profiles shown in FIGS. 29C and 29 D. Byway of example, FIG. 29C illustrates a circumferential stiffness profileat axial location A (as shown by reference ‘A’ in FIG. 29A). Similarly,FIG. 29D illustrates a circumferential stiffness profile at axiallocation B (as shown by reference ‘B’ in FIG. 29A). As the profileextends radially from the origin (indicated as ‘O’), the stiffness valueincreases.

Thus, as shown in FIG. 29C, the stiffness at S1 (90 degrees) is greaterthan the stiffness at S2 (270 degrees). Further to this example, in someembodiments, the circumferential portion from zero to 180 degrees canrepresent a relatively flat portion of an outer frame 820 of the outerframe assembly 810 having a D-shape configuration, and 180 to 360degrees can represent a relatively curved portion of the outer frame 820having the D-shape configuration.

In a similar fashion, FIG. 29D illustrates a circumferential stiffnessprofile at axial location B (as shown by reference ‘B’ in FIG. 29A). Asshown, axial location B has a different stiffness profile than axiallocation A. Such variability in design, as discussed above, can providefor advantageous customization of heart valve 800, and cooperation ofheart valve 800 with a native heart valve. Similar to FIG. 29C, FIG. 29Dillustrates the stiffness at one side of valve 800 being greater than astiffness at another side of the valve 800. In this manner, in someinstances, a portion of valve 800 that will experience greater forcesfrom the native heart valve annulus can have a smaller stiffness value(e.g., more compliant) than a portion of the valve 800 that willexperience smaller or fewer forces, thus optimizing the cooperation ofthe prosthetic heart valve 800 with the native heart (particularly thenative heart valve annular region).

As discussed above, in some instances, a patient having an implantedprosthetic heart valve may experience postoperative LVOT obstructionsresulting from, for example, subvalvular positioning or configuration ofthe prosthetic heart valve. Described below and illustrated in FIGS.30-35B are various embodiments of prosthetic heart valves, in expandedor deployed configurations, that are configured to avoid, reduce orotherwise limit undesirable LVOT obstruction. To assist in theunderstanding of the relationship between the various prosthetic valveembodiments and the anatomy of a heart, FIGS. 35A and 35B illustrate ina partial cross-sectional side view and top view, respectfully, anexemplary prosthetic heart mitral valve 1400 (also referred to herein as“valve”) implanted in a native mitral annulus of a heart. The prostheticheart mitral valve 1400 can be constructed and function similar to anyof the prosthetic heart valves described herein. For example the valve1400 can include an outer frame 1420 and an inner frame 1450. Thus, somedetails regarding the valve 1400 are not described below. It should beunderstood that for features and functions not specifically discussed,those features and functions can be the same as or similar to any of thevalves described herein.

As shown in FIGS. 35A and 35B, the prosthetic heart mitral valve 1400(also referred to herein as “valve”) in its expanded or deployedconfiguration is seated in the native mitral valve annulus NA betweenthe left ventricle LV and the left atrium LA of the heart H. Inoperation, the left ventricle LV contracts and blood flows outwardlyfrom the left ventricle LV through the aortic valve AV via the leftventricular outflow tract (LVOT). The path of such blood flow is shownin FIG. 35A by arrow LVOT. When the prosthetic heart valve 1400 isdeployed and seated in the native mitral valve annulus NA, as shown, theA2 segment 1447 of the outer frame 1420 of the valve 1400 (i.e., theanterior side of the valve 1400) is aligned with or seated at the A2anterior segment (labeled A2 in FIGS. 35A and 35B) of the native mitralvalve annulus. Further, as shown, when the valve 1400 is deployed andseated in the native mitral valve annulus NA, the P2 segment 1449 of theouter frame 1420 of the valve 1400 (i.e., the posterior side of thevalve 1400) is aligned with or seated at the P2 posterior segment(labeled P2 in FIGS. 35A and 35B) of the native mitral valve annulus.

As shown in FIG. 35A, during operation of the heart, the native leafletNL1 on the anterior side (native leaflet NL2 is on the posterior side)can intrude into the LVOT, identified by the change in position of thenative anterior leaflet NL1 from a first position shown in solid-line toa second position shown in dashed-line in which the leaflet NL1 intrudesinto or obstructs the LVOT.

In one embodiment, an outer frame of a prosthetic heart valve can beconfigured similar to the outer frames described above (e.g., the outerframe 520) except that the cuff portion is disposed at an angle (e.g.,less than 90 degrees) relative to the vertical axis of a body portion ofthe outer frame (also referred to herein as the “angled cuffarrangement” discussed in more detail below with reference to FIGS.30A-30C). In this manner, in use, a prosthetic heart valve can bedelivered and deployed to a native heart (i.e., seated in the nativeannulus of the heart) such that at least a portion of the prostheticheart valve disposed in the ventricle of the heart is oriented orpositioned away from the LVOT of the heart. As such, the angled cuffarrangement can prevent, reduce or otherwise limit LVOT obstruction (orintrusion by the native leaflet). Similarly stated, the angled cuffarrangement can provide additional LVOT clearance. As discussed above,an implanted prosthetic valve, or a portion thereof, can contribute tothe postoperative complication of LVOT obstruction. An angled cuffarrangement, however, can limit or prevent LVOT obstruction by limitingthe placement of the prosthetic valve in the LVOT of the heart.

FIG. 30A illustrates an outer frame 920 of a prosthetic heart valve 900having an angled cuff arrangement, and FIG. 30B illustrates a schematicside cross-sectional view of the prosthetic heart valve 900 shown inFIG. 30A, including an inner valve assembly 940. The prosthetic heartvalve 900 (also referred to herein as “valve”) can be constructed andfunction similar to any of the prosthetic heart valves described herein,e.g., the prosthetic heart valve 500. Thus, some details regarding thevalve 900 are not described below. It should be understood that forfeatures and functions not specifically discussed, those features andfunctions can be the same as or similar to any of the valves describedherein.

As shown in FIG. 30A, the outer frame 920 includes a coupling portion971, a body portion 972, and a cuff portion 973. When the valve 900 isdisposed within a native mitral annulus of a heart, the cuff portion 973is configured to be seated within the native mitral annulus and extendwithin the atrium of the heart and the body portion 972 is configured tobe disposed within a ventricle of the heart. The coupling portion 971 isconfigured to be coupled to the inner valve assembly. In thisembodiment, the cuff portion 973 is disposed at an angle α relative tothe vertical axis A. Said another way, as shown in FIG. 30A, the cuffportion 973 slopes downward from the anterior side of the valve 900 tothe posterior side of the valve 900. In this manner, when the prostheticheart valve 900 is implanted into a heart (e.g., when the cuff portion973 is seated in the native annulus of the heart), the angle of the cuffportion 973 will cause the body portion 972 of the valve 900 to beoriented or positioned away from the LVOT of the heart, therebypreventing, reducing or otherwise limiting undesirable LVOT obstruction.

An angle α defined by the cuff portion 973 and the vertical axis A ofthe prosthetic valve 900 can be any suitable value configured to create,increase or otherwise promote LVOT clearance and limit or prevent LVOTobstruction (or undesirable outflow gradients). The angle α can be, forexample, an acute angle. As shown in FIG. 30A, the angle α is about 80degrees. In other embodiments, however, the angle α can be, for example,from about 70 degrees to about less than 90 degrees. As the LVOT variesacross patients, e.g., depending on a patient's particular anatomy, theangle can be adjusted accordingly.

As shown in FIG. 30B, the body portion 972 of the outer frame 920 hasvarying lengths due to the angled cuff arrangement. More particularly,an anterior portion of the body portion 972 has an anterior length La1,and a posterior portion has a relatively smaller posterior length Lp1.The anterior length La1 and the posterior length Lp1 can be any suitablevalue configured to create, increase or otherwise promote LVOT clearanceand limit LVOT obstruction or undesirable outflow gradients. In someinstances, for example, the anterior length La1 can be about 18 mm andthe posterior length Lp1 can be about 14 mm. As the LVOT varies acrosspatients, e.g., depending on a patient's particular anatomy, theanterior length La1 and the posterior Lp1 can be adjusted accordingly.

Further, as shown in FIG. 30B, an atrial end portion 955 of the innervalve assembly 940 extends a length of Li1 from the location at whichthe inner valve assembly 940 is coupled to the outer frame 920 when theinner valve assembly 940 is seated in the outer frame 920. Also shown inFIG. 30B, in some embodiments, the inner valve assembly 940 (e.g., theinner frame 950 shown in FIG. 30C) can have a centerline substantiallyparallel to the centerline of the outer frame 920.

FIG. 30C shows a side view of the prosthetic heart valve 900 (with theangled cuff arrangement), in a deployed or biased configuration, and forcomparison, a side view of a prosthetic heart valve 900′ without theangled cuff arrangement. Both the valve 900 and the valve 900′ are shownsimilar to how each valve would be arranged when seated within a nativeannulus of a heart (not shown). The valve 900′, for example, can beconstructed and function similar to or the same as the prosthetic heartvalve 500.

As discussed with respect to FIGS. 35A and 35B, in operation, the leftventricle of the heart (not shown in FIG. 30C) contracts and blood flowsoutwardly from the left ventricle through the aortic valve via the LVOT.The path of such blood flow is shown in FIG. 30C by arrow LVOT. Asshown, the outer frame 920 of the valve 900 provides additional LVOTclearance when compared to the outer frame 920′ of the valve 900′. Forexample, as shown in FIG. 30C, the strut 954 of the inner frame 950 ofthe valve 900 is disposed a greater distance from and provides greaterclearance to the LVOT. As shown by comparison to the valve 900′, thestrut 954 of the inner frame 950 of valve 900 is displaced from thestrut 954′ of the inner frame 950′ of valve 900′, and a tether clamp orcoupling portion 944 of the inner frame 950 of valve 900 is displacedfrom a tether clamp or coupling portion 944′ of the inner frame 950′ ofthe valve 900′. In this manner, when the valve 900 is implanted in anative annulus of a heart, the valve 900 can provide clearance to the A2anterior segment of the native valve (e.g., the mitral valve) such thatinterruption of blood flow through the aorta, which anatomically sitsimmediately behind the A2 segment of the mitral annulus, can beprevented or limited.

In an alternative embodiment, an outer frame of a prosthetic heart valvecan be configured similar to the outer frame 920 of valve 900 having theangled cuff arrangement, except that a body portion and coupling portionof the outer frame has a shorter profile (also referred to herein as the“short profile arrangement”). In this manner, when the prosthetic heartvalve having a shorter profile is implanted into a heart (e.g., when thecuff portion is seated in the native annulus of the heart), at least aportion of the outer frame disposed in the ventricle of the heart (e.g.,the body portion and the coupling portion of the outer frame) ispositioned outside of or substantially away from the LVOT of the heart,thereby reducing the likelihood of undesirable postoperative LVOTobstruction.

FIG. 31A illustrates an outer frame 1020 of a prosthetic heart valve1000 having an angled cuff arrangement and a short profile arrangement.The prosthetic heart valve 1000 (also referred to herein as “valve”) canbe constructed and function similar to any of the prosthetic heartvalves described herein, e.g. the valve 900. Thus, some detailsregarding the valve 1000 are not described below. It should beunderstood that for features and functions not specifically discussed,those features and functions can be the same as or similar to any of thevalves described herein.

As shown in FIG. 31A, the outer frame 1000 includes a coupling portion1071, a body portion 1072, and a cuff portion 1073. The cuff portion1073 is disposed at an angle α relative to the vertical axis A. In thismanner, when the prosthetic heart valve 1000 is implanted into a heart(e.g., when the cuff portion 1073 is seated in the native annulus of theheart), the short profile of the body portion 1072 of the valve 1000 canbe oriented or positioned away from the LVOT of the heart, therebyproviding additional clearance to the LVOT preventing, reducing orotherwise limiting undesirable LVOT obstruction.

As shown in FIG. 31A, the body portion 1072 of the outer frame 1020 hasvarying lengths due to the angled cuff arrangement. More particularly,an anterior portion of the body portion 1072 has an anterior length La2,and a posterior portion of the body portion 1072 has a relativelysmaller posterior length Lp2. The anterior length La2 and the posteriorlength Lp2 can be any suitable value configured to create, increase orotherwise promote LVOT clearance and limit LVOT obstruction orundesirable outflow gradients. In some instances, for example, theanterior length La2 can be about 10 mm and the posterior length Lp2 canbe about 4 mm. As the LVOT varies across patients, e.g., depending on apatient's particular anatomy, the anterior length La2 and the posteriorLp2 can be adjusted accordingly.

FIGS. 31B and 31C illustrate schematic perspective and sidecross-sectional views of the prosthetic heart valve 1000 shown in FIG.31A, including an inner valve assembly 1040. The inner valve assembly1040 extends a length Li2 from the location at which the inner valveassembly 1040 is coupled to the outer frame 1020 when the inner valveassembly 1040 is seated in the outer frame 1020. In comparison to theembodiment described with respect to the valve 900 and FIGS. 30A and30B, the anterior length La2 of the valve 1000 (see e.g., FIGS. 31A-C)is less than the anterior length La1 of the valve 900 (see e.g., FIG.30B) and the posterior length Lp2 of the valve 1000 (see e.g., FIGS.31A-C) is less than the posterior length Lp1 of the valve 900 (see e.g.,FIG. 30B). The length Li2 of the inner valve assembly 1040 (see e.g.,FIGS. 30B and 30C), however, is equal to the length Li1 of the innervalve assembly 940 (see e.g., FIG. 30B). For example, as shown in FIG.30B, the atrial end portion 955 of the inner valve assembly 940 isdisposed below an atrial end 956 of the outer frame 920 when the innervalve assembly 940 is seated in and coupled to the outer frame 920, andas shown in FIGS. 31B and 31C, the atrial end portion 1055 of the innervalve assembly 1040 extends above at least a portion of an atrial end1056 of the outer frame 1020 when the inner valve assembly 1040 isseated in and coupled to the outer fame 1020. Thus, when the cuffportion 1073 is seated in a native annulus, the inner valve assembly1040 of valve 1000 sits higher into the atrium of the heart than wouldthe inner valve assembly 940 of the valve 900.

In an alternative embodiment, a prosthetic heart valve can be configuredsimilar to any of the prosthetic heart valves described herein, exceptthat the inner valve assembly of the prosthetic heart valve can bedisplaced radially (e.g., off-center) relative to the outer frameassembly of the prosthetic heart valve. In this manner, when theprosthetic heart valve is implanted into a heart (e.g., when the cuffportion is seated in the native annulus of the heart), the inner valveassembly, and thus the fluid flow path therethrough, are positionedfurther away from the LVOT of the heart, thereby reducing the likelihoodof undesirable postoperative LVOT obstruction or undesirable outflowgradients.

FIGS. 32A-32C illustrate a prosthetic heart valve 1100 having an outerframe 1120 (of an outer frame assembly, not shown) and an inner valveassembly 1140 coupled to and displaced radially (off-center) from theouter frame 1120. The outer frame 1120 includes a cuff portion 1173, abody portion 1150 and a coupling portion 1171.

The prosthetic heart valve 1100 (also referred to herein as “valve”) canbe constructed and function similar to any of the prosthetic heartvalves described herein, e.g., the valve 500. Thus, some detailsregarding the valve 1100 are not described below. It should beunderstood that for features and functions not specifically discussed,those features and functions can be the same as or similar to any of thevalves described herein.

For ease of explanation, the inner frame assembly 1140 is represented bya solid-lined circle. Further, as shown, for example, in FIG. 32A, thelower end of the coupling portion 1171 of the outer frame 1120 forms aroughly circular opening (shown as a dashed-line circle and identifiedby “O” in FIG. 32A). The radial displacement is represented by radialoff-set RO and is illustrated by the gap defined between the inner frameassembly 1140 and the circular opening O of the outer frame 1120 on anA2 segment or side 1147 of the outer frame 1120. Said another way, acenterline of the inner frame 1140 is radially offset from a centerlineof the outer frame 1120. In previous embodiments of a prosthetic valve,such as, for example, valve 500, the outer frame is configured to holdan inner valve assembly centered within circular opening O. In someembodiments, to accommodate the offset of the inner valve assembly asshown in FIG. 32A, the outer frame can be modified so that the circularopening O is aligned with the inner frame assembly (e.g., the centerlineof the inner frame and the center line of the outer frame are aligned orcoaxial). In other embodiments, the inner frame can be coupled to theouter frame in a manner to accommodate the offset.

The radial displacement RO can be any suitable value (i.e., distance)configured to create, increase or otherwise promote LVOT clearance andlimit LVOT obstruction or undesirable outflow gradients. As shown inFIG. 32A, the inner valve assembly 1140 is radially off-set towards a P2segment or side 1149 (i.e., posterior side) of the outer frame 1120 suchthat when the outer frame 1120 is seated in a native mitral annulus, theinner valve assembly 1140 is positioned further away from the LVOT. Theinner valve assembly 1140 can be displaced, for example, as far as theposterior sealing surface Ps of outer frame 1120 (e.g., as shown in FIG.32C). For example, as shown by comparing FIGS. 32B and 32C, the innerframe 1140 can be shifted from a substantially centered positionrelative to the outer frame 1120 (as shown in FIG. 32B (i.e.,substantially no radial offset)) to the posterior sealing surface Ps ofthe outer frame 1120 (as shown in FIG. 32C (i.e., radially offsetrelative to the outer frame 1120)) such that a gap G defined between theposterior side Pi of the inner valve 1140 and the posterior sealingsurface Ps of the outer frame 1120 decreases (e.g., g=0 when the innervalve assembly 1140 is displaced as far as the posterior sealing surfacePs of the outer frame 1120 such that a portion of the inner valveassembly 1140 is in contact with the posterior side of the outer frame1120, as shown in FIG. 32C).

The displacement away from the LVOT can be further increased by reducingthe diameter of the inner valve assembly. This is illustrated in FIG.32A, in which the inner frame assembly is slightly smaller in diameterthan the opening O of the outer frame. The effect on the displacementaway from the LVOT could be increased by further reducing the diameterof the inner valve assembly.

In use, when the prosthetic heart valve 1100 is implanted into a heart(e.g., when the cuff portion 1173 is seated in the native mitral annulusof the heart), for example, the blood flow from the left atrium to theleft ventricle through the leaflet assembly (not shown) of the innervalve assembly 1140 is directed to avoid LVOT obstruction or undesirableoutflow gradients. Similarly stated, the inner valve assembly 1140 andthe outer frame 1120 can be collectively configured to manage desirableblood flow from the atrium to the ventricle of the heart withoutinterrupting or otherwise promoting undesirable affects to the LVOT.

In another alternative embodiment, a prosthetic heart valve can beconfigured similar to any of the prosthetic heart valves describedherein except that the inner valve assembly of the prosthetic heartvalve can be rotated about its vertical axis and relative to the valve'souter frame. More specifically, the inner frame can be rotated such thatthe A2 segment of the outer frame is aligned with a commissure post ofthe inner frame of the inner valve assembly rather than a belly of aleaflet (each portion of the leaflets between adjacent commissure postsbeing referred to as a “belly” of a leaflet) and correspondingly with abelly post of the inner frame of the inner valve assembly. As discussedabove in connection with the embodiment of FIGS. 2A-2C, and apparentfrom FIG. 12 in connection with the embodiment of FIGS. 7-18, thecommissure posts 152 lie on a slightly smaller diameter circle than thebelly posts 154. Thus, orienting the inner valve so that a belly post(and leaflet belly) is closest to the LVOT, positions the portion of theinner valve body closest to the LVOT slightly further away from theLVOT.

FIG. 33A is a top view of a prosthetic heart valve 1200 having an outerframe 1220 (of an outer frame assembly, not shown) and an inner frame1250 (of an inner valve assembly, not shown). As shown, the inner frame1250 is coupled to the outer frame 1220 and rotated about its verticalaxis (i.e., the axis extending through the centerline of the inner frame1250 (see e.g., a top view of the vertical axis identified as “VA” inFIG. 33A) relative to the outer frame 1220. As such, an A2 segment 1247of the outer frame 1220 is aligned with a commissure post 1252 of theinner frame 1250 and not aligned with a leaflet belly (the location ofwhich is identified by “LB” in FIG. 33A) or a belly post 1254 of theinner frame 1250 as described in more detail below.

The prosthetic heart valve 1200 (also referred to herein as “valve”) canbe constructed and function similar to any of the prosthetic heartvalves described herein, e.g., the valve 500. Thus, some detailsregarding the valve 1200 are not described below. It should beunderstood that for features and functions not specifically discussed,those features and functions can be the same as or similar to any of thevalves described herein.

As shown in FIG. 33A, the outer frame 1220 of the valve 1200 includesthe A2 segment 1247 and a P2 segment 1249. The inner frame 1250 includesan inner wireframe structure made of Nitinol wire that supports leaflets(not shown) sewn to the inner frame 1250 and functions as a valve. Theinner frame 1250 includes three main U-shaped wire components 1207joined at their opened ends to form junctions 1202 (see FIG. 33A).Prosthetic leaflets (not shown) are sewn to these components to formarticulating leaflets, creating and functioning as a prosthetic valve(e.g., a prosthetic mitral valve). The inner frame 1250 also includesthree commissure posts 1252-1, 1252-2, 1252-3 and three belly posts1254-1, 1254-2, 1254-3 (as shown in FIGS. 33A and 33B).

As shown, for example, in FIG. 33A, the inner frame 1250 and the outerframe 1220 are positioned/oriented relative to each other such that acenter portion CP of the A2 segment 1247 of the outer frame 1220 isaligned with the commissure post 1252-1 of the inner frame 1250.Further, the belly posts 1254-1 and 1254-2 on each side of thecommissure post 1252-1 are misaligned with the center portion CP of theA2 segment 1247 of the outer frame 1220. Said another way, the bellyposts 1254-1 and 1254-2 on each side of the commissure post 1252-1 ofthe outer frame 1220 are disposed relative to a horizontal axis B (whichpasses through the center portion CP of the A2 segment 1247) by an angleβ, as shown in FIG. 33A. In this embodiment, the angle β is about 60degrees. In alternative embodiments, an angle β can be any suitablevalue configured to position the inner frame to the outer frame suchthat the belly posts 1254-1 and 1254-2 are misaligned with the centerportion CP of the A2 segment of the outer frame.

FIG. 33B illustrates a bottom view of the inner frame 1250 to furtherillustrate the position of the inner frame 1250 relative to the A2segment 1247 of the outer frame 1220. As shown in FIG. 33B, the bellyposts 1254-1, 1254-2, 1254-3 define an outer perimeter or circle CPC andthe commissure posts 1252-1, 1252-2, 1252-3 are each disposed within thecircle CPC such that a space SP is defined between the circle CPC andeach of the commissure posts 1252-1, 1252-2, 1252-3. The space SPbetween the commissure post 1252-1 and the center portion CP of the A2segment of the outer frame 1250 provides additional clearance to theLVOT when the prosthetic valve 1200 is seated in a native annulus of aheart.

In another alternative embodiment, a prosthetic heart valve can beconfigured similar to any of the prosthetic heart valves describedherein, except that the post of the inner frame that is aligned with theA2 segment of the outer frame (a commissure post or a belly post) isradially compressed (or pushed-in) (e.g., about 2-3 mm) when the innervalve assembly and the outer valve assembly are coupled to each otherand in their deployed or biased configuration. In this manner, when theprosthetic heart valve is implanted into a heart (e.g., when the cuffportion is seated in the native annulus of the heart), the portion ofthe inner valve assembly that is closest to the LVOT, i.e., thecompressed or pushed-in post of the inner frame, is further away fromthe LVOT, and thus provides more clearance to the LVOT of the heart. Anexample of such an embodiment is described below.

FIGS. 34A and 34B illustrate an embodiment of a prosthetic valve inwhich a portion of a prosthetic valve to be positioned on the anteriorside of the mitral annulus can be formed or shaped to achieve additionalclearance to the LVOT. For example, FIG. 34A illustrates a prostheticheart valve 1300, in its deployed or biased configuration, with a strut1354 (e.g., belly post) of its inner frame 1350, which is aligned withand coupled to the A2 segment 1347 of the outer frame 1320, is displaced(e.g., compressed or pressed-in) perpendicular to the corner of theouter frame 1320 (when viewed in the side view of FIG. 34A). FIG. 34Bshows a prosthetic heart valve for comparison with a strut 1354′(corresponding to strut 1354 in FIG. 34A) of its inner frame notdisplaced.

The prosthetic heart valve 1300 (also referred to herein as “valve”) canbe constructed and function similar to any of the prosthetic heartvalves described herein, e.g., the valve 500. Thus, some detailsregarding the valve 1300 are not described below. It should beunderstood that for features and functions not specifically discussed,those features and functions can be the same as or similar to any of thevalves described herein.

As shown in FIG. 34A, the prosthetic heart valve 1300 has an inner frame1350 and an outer frame 1320 coupled to the inner frame 1350. The innerframe 1350 includes three main-U-shaped wire components 1307 joined attheir open ends to form junctions 1302. Prosthetic leaflets (not shown)are sewn to these components to form articulating leaflets, creating andfunctioning as a prosthetic valve (e.g., a prosthetic mitral valve). Inthis example embodiment, a strut 1354 of the inner frame 1350 that isaligned with the A2 segment 1347 of the outer frame 1320 is disposed ina displaced position perpendicular to a corner portion of the outerframe 1320. For ease of explanation, FIG. 34A illustrates (and partiallyexaggerates) the displacement of the strut 1354 in a direction P from afirst position (shown by the dashed curved line) to a second position,as shown by the actual position of the strut 1354 within the valve 1300.In this manner, when the prosthetic heart valve 1300 is implanted into aheart (e.g., when the cuff portion is seated in the native annulus ofthe heart), the inner frame 1350 is prevented or limited frominterrupting the LVOT. In other words, as discussed above, it isadvantageous for the valve 1300 to be disposed at a distance away fromthe A2 anterior segment of the native valve (e.g., the mitral valve) toprevent interruption of blood flow through the aorta, which anatomicallysits immediately behind the A2 segment of the mitral annulus. To achievethe displacement of the strut 1354, the valve can be formed/constructedand then the strut 1354 can be displaced by compressing or pushing thestrut in the perpendicular direction as discussed above. Alternatively,the prosthetic valve 1300 can be formed/constructed with the strutconfigured to provide the desired clearance on the A2 side of the valve.The strut 1354 can be pressed-in (or heat set) any suitable distanceconfigured to clear the strut from contributing to LVOT obstructionwhile providing appropriate structural support to the inner valveassembly and without interrupting functioning of the inner valveassembly. In some embodiments, for example, the strut can be pressed-inor offset about 2-3 mm.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation, and as such, various changes in form and/or detail may bemade. Any portion of the apparatus and/or methods described herein maybe combined in any suitable combination, unless explicitly expressedotherwise. Where methods and/or schematics described above indicatecertain events occurring in certain order, the ordering of certainevents and/or flow patterns may be modified. Additionally, certainevents may be performed concurrently in parallel processes whenpossible, as well as performed sequentially.

What is claimed is:
 1. A prosthetic heart valve, comprising: an outerframe assembly including an outer frame having a cuff portion configuredto be disposed at least partially within an atrium of a heart and a bodyportion configured to be disposed in a ventricle of the heart; and aninner valve assembly including an inner frame having an atrium end and aventricle end and a valve leaflet assembly supported on the inner frame,the inner frame further including a plurality of posts, the inner valveassembly disposed within and coupled to the outer frame assembly suchthat one post from the plurality of posts is substantially aligned witha center portion of an A2 segment of the outer frame, wherein the innerframe defines a perimeter and the one post is spaced a radial distancefrom the perimeter toward a radial center of the inner frame relative toall other posts from the plurality of posts other than the one post,wherein the plurality of posts of the inner frame includes a pluralityof belly posts and a plurality of commissure posts, the postsubstantially aligned with the center portion of the A2 segment of theouter frame being a belly post from the plurality of belly posts.
 2. Theprosthetic heart valve of claim 1, wherein the center portion of the A2segment of the outer frame is misaligned with each commissure post fromthe plurality of commissure posts of the inner frame.